Advocacy Group Releases Patient Guide to Biosimilar Therapies

CreakyJoints, a patient organization that is part of the Global Healthy Living Foundation (GHLF), has released the first edition of its patient guide to biosimilar medicines.

Jonathan Kay, MD, a professor of medicine and the Timothy S. and Elaine L. Peterson chair in rheumatology at the University of Massachusetts Medical School in Worcester, Massachusetts, provided medical review of the guide, and patients with inflammatory diseases also provided a review to ensure that the guide is relatable for patients.

The guide, which focuses on biosimilars relevant to CreakyJoints’ community of patients with inflammatory diseases, answers such questions as “What is a biosimilar?” and “Are biosimilars the same as generic drugs?” in addition to providing a list of FDA-approved antirheumatic biosimilars in the United States and links to patient assistance programs.

In its detailed answers to commonly asked questions, the guide explains that biosimilars work in exactly the same way, have the same risks, are administered in the same way, and have the same dosages as their reference products. The guide also explains the regulatory process for biosimilars, the safety of these products, the history of the biosimilar approval pathway in the United States, the naming conventions for biosimilars, and the kinds of studies undertaken by developers to demonstrate that biosimilars are as safe and effective as their references. Notably, in its discussion of interchangeable biologics, the guide underscores the fact that an interchangeability designation does not mean that a biosimilar is more safe or effective than an FDA-approved biosimilar without such a designation.

The guide also addresses the crucial issue of biosimilars’ costs to patients. “The savings to patients do not appear to be as large, or exist at all, as many proponents of biosimilars initially suggested,” explains the guide. “There may be savings to the healthcare systems like Medicare and Medicaid, or to insurance companies, but these savings have not yet been passed on directly to patients in the form of lower copays, deductibles, or premiums.” The resource goes on to explain the difference between drugs’ list prices and what patients pay out-of-pocket for their therapies.

In an interview with The Center for Biosimilar^®, Louis Tharp, cofounder and executive director of GHLF, said that, when it comes to patients’ willingness to accept biosimilars, it is not necessarily the safety or effectiveness of the products that patients are concerned about; “Cost is the fulcrum here,” said Tharp. If patients were able to realize an out-of-pocket cost savings of 50% or more with biosimilars as they can with many generics, then patients would be likely to act in their own best financial interests and switch to a biosimilar, he said.

However, given the fact that savings from biosimilars are not passed to patients, it is little wonder that individuals see no incentive to change from therapies on which they are stable to products that may only provide theoretical savings to the healthcare system at large.

“The concern that we have is that, when biosimilars were first introduced, people talked about billons in savings, but they conveniently forgot to mention who was going to participate in those savings,” said Tharp. As long as pharmacy benefit managers reap most of the gains from biosimilars, he explained, then stakeholders can expect uptake among patients to be low. “If we can structure an economic model that lets patients participate in savings,” said Tharp, “then we’re in favor of biosimilars.”